AN2300.50 Tyvek Pouch, 50 count AN2300.50

GUDID 05060485030782

AN2300.50 Tyvek pouch

ANDERSEN STERILIZERS INC.

Sterilization packaging, single-use

• Primary Device ID: 05060485030782
• NIH Device Record Key: 77a5c64f-e335-4d62-b8d8-ab86514a1074
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AN2300.50 Tyvek Pouch, 50 count
• Version Model Number: AN2300.50
• Catalog Number: AN2300.50
• Company DUNS: 931853006
• Company Name: ANDERSEN STERILIZERS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 336-376-3000
• Email: faith.rios@sterility.com
• Phone: 336-376-3000
• Email: faith.rios@sterility.com
• Phone: 336-376-3000
• Email: faith.rios@sterility.com
• Phone: 336-376-3000
• Email: faith.rios@sterility.com
• Phone: 336-376-3000
• Email: faith.rios@sterility.com
• Phone: 336-376-3000
• Email: faith.rios@sterility.com
• Phone: 336-376-3000
• Email: faith.rios@sterility.com
• Phone: 336-376-3000
• Email: faith.rios@sterility.com
• Phone: 336-376-3000
• Email: faith.rios@sterility.com
• Phone: 336-376-3000
• Email: faith.rios@sterility.com
• Phone: 336-376-3000
• Email: faith.rios@sterility.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060485030782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200336

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-22
• Device Publish Date: 2025-12-12

Devices Manufactured by ANDERSEN STERILIZERS INC.

• 05060485030782 - AN2300.50 Tyvek Pouch, 50 count: 2025-12-22AN2300.50 Tyvek pouch
• 05060485030782 - AN2300.50 Tyvek Pouch, 50 count: 2025-12-22 AN2300.50 Tyvek pouch
• 05060485030683 - AN1036.00 Dosimeter, 14 Units EOG4 3&6 Hour Exposure: 2023-09-08 Indicator, sterilization process, 14 count
• 05060485030706 - AN4000.60 EOGas 4 Ethylene Oxide Gas Sterilizer, 115V: 2023-09-08 EOGas 4 Sterilizer with 3 & 6 hour cycle options, 115V
• 05060485030713 - AN4000.61 EOGas 4 Ethylene Oxide Gas Sterilizer, 230V: 2023-09-08 EOGas 4 Sterilizer 3 & 6 Hour Cycle, 230V
• 05060485030737 - AN4000.66 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 120V: 2023-09-08 EOGas 4 Sterilizer 3 & 6 hour cycle Stainless Steel Cabinet, 120V
• 05060485030744 - AN4000.67 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 230V: 2023-09-08 EOGas 4 Sterilizer 3 & 6 hour cycle, stainless steel cabinet, 230V
• 05060485030607 - Anprolene AN75 Ethylene Oxide Sterilizer: 2020-08-24 AN75.64 - Anprolene AN75 Sterilizer, 115V
• 05060485030614 - Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V: 2020-08-24 AN75.65 - Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V